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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.
ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.
Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.
ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.
Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.
ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.
ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.
DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.
Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.
Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.
Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.
GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.
B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.
B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.
Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.
The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.
Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.
Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.
Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.
Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.
The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.
Aesculap Implant Systems is recalling 80 units of the PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM because the implant may fail to deploy during surgery, potentially requiring additional medical intervention.
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